Validation Testing Engineer
hace 6 días
BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.
We are seeking a Validation Engineer – Software Validation (Automation) with strong experience in industrial automation systems, PLC-based equipment, and validation documentation within regulated environments. The ideal candidate will support and lead validation activities for software-controlled automated systems, ensuring compliance with applicable regulatory requirements and internal quality standards.
KEY RESPONSIBILITIES:
Lead and support validation activities for software-controlled automated equipment and systems, ensuring compliance with medical device regulations and internal quality standards.
Develop, review, and execute validation deliverables including URS, Risk Assessments, IQ/OQ/PQ protocols, test scripts, and validation reports.
Ensure appropriate traceability from requirements to testing through a Traceability Matrix and evidence collection.
Program, troubleshoot, and support industrial automation systems using Allen Bradley and Siemens PLCs.
Validate automation functionality including PLC logic, HMI/SCADA interfaces, alarms, interlocks, recipes, and system security where applicable.
Integrate and validate automation components such as vision systems, sensors, and communication interfaces (e.g., Ethernet/IP, Profinet).
Support investigations, deviations, and remediation activities related to automation and validation (e.g., CAPA, change control, revalidation).
Collaborate with Manufacturing, Quality, IT, Engineering, and Maintenance to ensure equipment readiness and validated state is maintained.
Participate in continuous improvement initiatives to enhance system reliability, efficiency, and compliance.
Provide technical support and training to operations and maintenance teams on validated systems and procedures.
Ensure adherence to safety, quality, and regulatory requirements (e.g., FDA, ISO 13485, and applicable GMP standards).
QUALIFICATIONS:
Bachelor's degree in Electrical Engineering, Mechatronics, Automation, Software Engineering, or related field.
Indispensable 3–5 years of experience in validation and/or automation engineering roles within regulated industries (medical device).
Hands-on experience with PLC-based automation systems (Allen Bradley and/or Siemens).
Experience generating and executing validation protocols such as IQ/OQ/PQ, including testing and documentation practices.
Knowledge of HMI development and SCADA systems and their validation considerations.
Familiarity with vision systems and integration/validation of sensors and inspection systems.
Strong understanding of documentation control, traceability, and compliance requirements.
Strong analytical, troubleshooting, and problem-solving skills.
Intermediate to advanced English proficiency (written and verbal).
PREFERRED QUALIFICATIONS:
Familiarity with Computer System Validation (CSV) concepts and best practices.
Knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles (ALCOA+), if applicable.
Experience with validation in manufacturing equipment such as assembly machines, inspection systems, testers, or packaging automation.
Experience supporting audits and regulatory inspections.
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